FDA Adverse Event
Death
Summary report: N
PIN MULTIHOLE II ACE CUP 62MM
MDR report key: 541510
·
Received August 31, 2004
Report
- Report Number
- 1818910-2004-00592
- Event Type
- Death
- Date Received
- August 31, 2004
- Date of Event
- July 15, 2003
- Report Date
- August 10, 2004
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLINICAL REPORT STATES PT'S PRIMARY DIAGNOSIS WAS REVISION IMPLANT LOOSENING, TYPE COMPLICATION STATES POST OPERATIVE AND COMPLICATION STATES DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIN MULTIHOLE II ACE CUP 62MM | TOTAL HIP REPLACEMENT | LPH | DEPUY ORTHOPAEDICS, INC. | NA | WP8GK1009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death| R |